摘要
通过对美国药品生产企业上市后监测制度的介绍,全面了解美国药品生产企业不良事件报告概况、强化药品生产企业上市后监测的管理要素以及监管机构内部的协调管理机制,为完善和发展我国药品生产企业不良反应报告和监测制度体系提供借鉴和参考。
By introducing the system of drug manufacture post marketing surveillance in the United States, it helped to know the general situation of manufacture adverse event reporting, supervision elements to strengthen manufacture post marketing surveillance and the coordination mechanism of internal organizations. It provided the example and reference for perfecting and developing adverse drug reaction reporting and monitoring system of drug manufacture in China.
出处
《中国药物警戒》
2013年第8期456-459,463,共5页
Chinese Journal of Pharmacovigilance
关键词
美国
药品
生产企业
上市后监测
药物警戒
the United States
drug
manufacture
post marketing surveillance
pharmacovigilance
